Cepheid readies for 2016 launch of point-of-care molecular Dx system for use anywhere

GeneXpert Omni--Courtesy of Cepheid

Diagnostics are not just breaking out of the lab. Now they're about to be available anywhere the patient is with a new device from Cepheid ($CPHD) that it says is the first point-of-care diagnostic device intended for such a broadly defined area of use. The company is unveiling the device at this week's American Association for Clinical Chemistry meeting in Atlanta, GA.

Called the GeneXpert Omni, the system is expected to be available outside the U.S. during the first half of 2016 and in the U.S. for commercial customers in late 2016. The system will eventually run the company's existing Xpert test cartridges; 23 of these are already offered ex-U.S. and 17 are available in the U.S. across infectious disease, sexual health and oncology applications.

Next year, Cepheid expects to have 5 Xpert tests available that are compatible with the GeneXpert Omni system including  tuberculosis, HIV, HCV and Ebola. By 2018, it expects that it will have versions for the system of all its currently existing tests.

But Cepheid also anticipates it will have some Xpert Xpress tests available around the launch, including ones for Group A Strep and Flu/RSV, which are designed specifically for the device and run assays much faster. The Xpert Xpress tests are being designed to run in 15 to 30 minutes and cost less than $15.

"Cepheid expects to launch faster Xpert tests in conjunction with the availability of the GeneXpert Omni," said Cepheid CMO and CTO Dr. David Persing in a statement. "Compared to an average run-time of about an hour today, we are further optimizing every stage within the cartridge with a goal of delivering test results in as little as 15 minutes, starting with our Xpert Group A Strep assay."

The device will be rolled out in developing nations via a collaboration with the nonprofit Foundation for Innovative New Diagnostics (FIND). The GeneXpert Omni is wireless and Internet-connected. It stands only 9 inches tall and weighs 2.2 pounds. It's expected to have a price of $2,895.

"The majority of people in the developing world still lack access to adequate tests for common diseases, and Cepheid's GeneXpert Omni has the potential to be a breakthrough platform on the path to achieving universal diagnosis," said CEO of FIND Dr. Catharina Boehme in a statement.

Added the World Health Organizations's Global TB Program Director Dr. Mario Raviglione, "This new point‐of‐care diagnostic platform has the potential to transform our capacity to detect the world's missing 3 million TB cases. Innovation in TB research and development is a critical pillar of WHO's End TB strategy. This ground‐breaking, battery‐operated technology, which can be used in microscopy centers with limited electrical supply, may bring us one step closer to ending the TB epidemic by 2035."

- here's the release